Soltamox 10mg/5ml oral solution

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Tamoxifen citrate

可用日期:

Rosemont Pharmaceuticals Ltd

ATC代码:

L02BA01

INN（国际名称）:

Tamoxifen citrate

剂量:

2mg/1ml

药物剂型:

Oral solution

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 08030401; GTIN: 5016119164897

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JOB INFORMATION
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PREFLIGHT
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JOB SPECIFICATION
MAIN BODY TEXT
Univers LTD Std 55 Roman
UNIVERS LTD STD 65 BOLD
10mg/5ml
BLACK
7474
PANTONE
PANTONE
265
KEYLINE
BRAILLE
UKL413
339
150 x 500mm
N/A
150 x 33mm
1
9.2pt
No
150ml
150ml
N/A
G8KD1RBJ1
P0750
N/A
1 of 2
Tamoxifen Rosemont 10mg/5ml Oral Solution
15/12/16
-
DH
-
2
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APPROVALS
THIRD PARTY APPROVAL REQUIRED
Name:
Name:
Signature:
Signature:
Date:
Date:
AUTHORITY APPROVAL SUPPLIED
REGULATORY SIGN-OFF
YES
YES
NO
N/A
TICK APPLICABLE BOX
TICK APPLICABLE BOX
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.
n
Keep this leaflet. You may need to read it again.
n
If you have any further questions, ask your doctor or
your pharmacist.
n
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
n
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Tamoxifen Rosemont is and what it is used for
2. What you need to know before you take Tamoxifen Rosemont
3. How to take Tamoxifen Rosemont
4. Possible side effects
5. How to store Tamoxifen Rosemont
6. Contents of the pack and other information
1. WHAT TAMOXIFEN ROSEMONT IS AND WHAT IT IS USED FOR
The name of your medicine is Tamoxifen Rosemont (called Tamoxifen in
this leaflet). It contains
tamoxifen citrate. This belongs to a group of medicines called
anti-oestrogens.
Tamoxifen is used to treat breast cancer.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMOXIFEN ROSEMONT
DO NOT TAKE TAMOXI

产品特点

OBJECT 1
TAMOXIFEN ROSEMONT 10MG/5ML ORAL SOLUTION
Summary of Product Characteristics Updated 20-Apr-2017 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Tamoxifen Rosemont 10mg/5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml dose of oral solution contains tamoxifen 10mg (as tamoxifen
citrate)
Excipients with known effect:
Ethanol - 750mg per 5ml
Sorbitol solution (non-crystallising) (E420) - 1g per 5ml
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Solution
A clear colourless liquid
4. Clinical particulars
4.1 Therapeutic indications
- Adjuvant treatment of oestrogen-receptor positive early breast
cancer
- Treatment of oestrogen-receptor positive locally advanced or
metastatic breast cancer
4.2 Posology and method of administration
Posology
Adjuvant treatment of breast cancer, Adults (including elderly):
The recommended dose is 20mg, given either in divided doses twice
daily or as a single dose once daily.
The current recommended treatment duration is five years; however the
optimum duration has not been
established.
Treatment of locally advanced or metastatic breast cancer:
The recommended dose is 20mg to 40mg, given either in divided doses
twice daily or as a single dose
once daily.
Paediatric Population
Children: Not applicable.
Method of Administration
For oral use.
4.3 Contraindications
Pregnancy and lactation
Hypersensitivity to tamoxifen or to any of the excipients listed in
section 6.1
Concurrent anastrozole therapy (see section 4.5)
4.4 Special warnings and precautions for use
Premenopausal patients must be carefully examined before treatment to
exclude pregnancy.
Women should be informed of the potential risks to the foetus, should
they become pregnant whilst taking
tamoxifen; or within two months of cessation of therapy.
A number of secondary primary tumours, occurring at sites other than
the endometrium and the opposite
breast, have been reported in clinical trials, following the treatment
of breast cancer patients with
tamoxif